This follow-up mdr is created to document the conclusion of the investigation.Requests for the explanted prosthesis and for additional information surrounding this event have been made.However, to date neither the device nor the information has been received.Without the benefit of analyzing the explant and without the requested information, quality cannot comment on the condition of the device or the events surrounding this incident.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconformance's revealed no nonconformance with this lot that would have contributed to the event.The most likely root cause of the event cannot be determined at this time.Based on the available information, quality accepts the physician's observations of reservoir herniation as the reason for surgical intervention.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.
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